Boston Scientific Corp. - BSX STOCK NEWS

Boston Scientific announced positive three-year results from the OPTION clinical trial of its WATCHMAN FLX™ Left Atrial Appendage Closure Device. The study compared the device to oral anticoagulation (OAC) for stroke risk reduction in patients with non-valvular atrial fibrillation following cardiac ablation. The device showed superior bleeding risk reduction (8.5% vs 18.1%) and non-inferior efficacy in preventing death, stroke, or systemic embolism (5.4% vs 5.8%) compared to OAC. The trial included 1,600 patients across 114 sites, with approximately 60% receiving the implant 90-180 days post-ablation and 40% during the same procedure.

Boston Scientific (NYSE: BSX) has completed its acquisition of Axonics (Nasdaq: AXNX), a medical technology company specializing in devices for urinary and bowel dysfunction treatment. The acquisition, valued at $3.7 billion in equity value and $3.3 billion in enterprise value, was completed at $71 cash per share. The deal expands Boston Scientific's Urology business into sacral neuromodulation, a high-growth market. The transaction is expected to be immaterial to adjusted earnings per share in 2024 and 2025, becoming accretive thereafter, though potentially less accretive or more dilutive on a GAAP basis due to amortization and acquisition costs.

SoniVie , a medical device company developing a renal denervation system for hypertension treatment, has appointed Raymond W. Cohen as Chairman of its Board of Directors. Cohen, who is retiring from Axonics following its $3.7 billion sale to Boston Scientific , brings significant experience in the medical technology sector. He previously served as CEO of Axonics, which he co-founded in 2013 and led to become the top-ranked company in the 2021 Deloitte Technology Fast 500™. Cohen also has relevant expertise in renal denervation from his time as CEO of Vessix Vascular, which was acquired by Boston Scientific in 2012.

Boston Scientific (NYSE: BSX) has announced its participation in the 2024 UBS Global Healthcare Conference scheduled for Tuesday, November 12, 2024. The company will be represented by Nick Spadea-Anello, president of Electrophysiology, and Jon Monson, senior vice president of Investor Relations, who will engage in a 35-minute Q&A session starting at 7:15 a.m. PT / 10:15 a.m. ET. The session will be available via live webcast, with a replay accessible approximately one hour after the event's conclusion on the company's investor relations website.

Boston Scientific (NYSE: BSX) has announced a definitive agreement to acquire Cortex Inc., a private medical technology company specializing in diagnostic mapping solutions for atrial fibrillation (AF). The key asset is the OptiMap™ System, which received FDA 510(k) clearance in 2023. The system uses a basket catheter and proprietary algorithm to identify AF sources, enabling targeted ablation strategies.

Clinical data from the FLOW-AF trial showed OptiMap-guided treatment improved freedom from AF by 51% compared to conventional therapy. The acquisition is expected to close in first half 2025, with immaterial impact on adjusted EPS and slight GAAP dilution. The ongoing RESOLVE-AF trial is evaluating the system's effectiveness across 300 patients globally.

Boston Scientific (NYSE: BSX) announced results from the ACURATE IDE clinical trial evaluating their ACURATE neo2™ Aortic Valve System for treating severe aortic stenosis. The trial's primary endpoint showed a 16.16% composite rate of all-cause mortality, stroke, or rehospitalization at one year in the ACURATE neo2 arm versus 9.53% in the control arm, failing to meet non-inferiority criteria. A post-hoc analysis revealed approximately 20% of valves were under-expanded, with data showing similar outcomes between properly expanded ACURATE neo2 valves and the control group. The company continues working with the FDA on regulatory approval strategy.

Boston Scientific (BSX) reported strong Q3 2024 results with net sales of $4.209 billion, representing a 19.4% increase year-over-year. The company achieved adjusted EPS of $0.63, exceeding guidance of $0.57-$0.59. Notable segment growth includes Cardiovascular at 25.0% and MedSurg at 10.3%. Regional performance showed U.S. sales growth of 23.5% and EMEA growth of 15.2%. The company received multiple regulatory approvals, including FDA approval for the FARAWAVE™ NAV Ablation Catheter and completed the acquisition of Silk Road Medical. For full-year 2024, BSX projects net sales growth of approximately 16.5% on a reported basis.

Boston Scientific (NYSE: BSX) has received FDA approval for the FARAWAVE™ NAV Ablation Catheter and FDA 510(k) clearance for the FARAVIEW™ Software. These technologies enhance the FARAPULSE™ Pulsed Field Ablation (PFA) System for treating paroxysmal atrial fibrillation (AF).

The FARAWAVE NAV Ablation Catheter adds magnetic navigation capabilities, allowing cardiac mapping and PFA therapy delivery in a single integrated catheter. The FARAVIEW Software provides visualization for cardiac ablation procedures, offering a dynamic view of catheter placement, shape, and rotation.

These advancements are designed to increase confidence in therapy delivery and simplify mapped workflows during PFA procedures. The FARAPULSE PFA System has been used to treat over 125,000 patients globally. Boston Scientific will immediately launch these new technologies in the U.S.

Boston Scientific (NYSE: BSX) has announced two upcoming events:

1. A conference call on October 23, 2024, at 8:00 a.m. ET to discuss third quarter 2024 financial results and business highlights. The call will be hosted by Mike Mahoney, chairman and CEO, and Dan Brennan, executive VP and CFO. Financial results will be released prior to the call.

2. A virtual investor event on October 30, 2024, from 4:00 – 5:00 p.m. ET following the Transcatheter Cardiovascular Therapeutics (TCT) symposium. This event will feature a cardiology business update and Q&A session with key executives from the company's cardiology division.

Live webcasts and replays for both events will be available on the Boston Scientific investor relations website.